Trial Comparing Peripheral I.V. Catheter Complication Rates of Two Different Catheter Dressings

Not Applicable

Terminated

• Conditions: Surgery
• Interventions: Device: New PIV Dressing; Device: Standard PIV Dressing

• Registration Number: NCT02725788
• Lead Sponsor: Solventum US LLC

Brief Summary

A multi-center randomized control trial comparing the dressing wear times of two different transparent film dressings when used to secure peripheral intravenous catheters of hospitalized adult patients.

Detailed Description

A multi-center, prospective, randomized control trial comparing the dressing wear time, complication rates and cost of two different transparent film dressing when used as intended for peripheral intravenous catheter site protection and securement in five U.S. hospitals.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-01-15
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Study First Submitted QC: 2016-03-29
• Study First Posted: 2016-04-01
• Results First Submitted: 2017-03-13
• Results First Submitted QC: 2017-03-13
• Results First Posted: 2017-04-24
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 247

Inclusion Criteria

1. At least 18 years of age, or of consenting age;
2. Admitted or going to be admitted to the hospital;
3. Requires peripheral IV therapy (catheter) for an anticipated 72 hours or longer;
4. Has an insertion site in the forearm or hand free of phlebitis, infiltration, dermatitis, burns, lesions or tattoos;
5. Demonstrates cooperation with a catheter insertion and the securement protocol; and
6. Patient or legally authorized representative is willing and able to provide written informed consent and authorization for use and disclosure of Protected Health Information

Exclusion Criteria

1. Is a current participant or a past participant in this study;
2. If the subject already has a functioning PIV in place, not requiring a replacement catheter
3. If the study PIV catheter site will be placed below an old infusion site;
4. If the study PIV site needs to be immobilized with a splint or other device;
5. Has a documented or a known allergy or sensitivity to a medical adhesive product such as transparent film adhesive dressings, tapes, or liquid skin protectants;
6. Requires the application of a gauze pad, a topical ointment or solution under the dressing in addition to the prep(s) required in the protocol;
7. Will require a power injection through the study PIV catheter for a radiologic procedure during participation in this study;
8. Will require a numbing agent prior to PIV insertion; or
9. Will require the use of ultrasound for the PIV catheter insertion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New PIV Dressing	New PIV Dressing	Bordered, notched dressing that covers, secures peripheral intravenous (PIV) catheter
Standard PIV Dressing	Standard PIV Dressing	Film,adhesive dressing that covers, secures peripheral intravenous (PIV) catheter and used with a medical grade tape

Primary Outcome Measures

Name	Time	Method
Dressing Wear Time	Dressing wear time was assessed daily and 8 month dressing wear data are presented	Dressing wear time is the time from dressing application to removal, i.e. catheter no longer needed or catheter-related complication occurs (remove dressing and catheter) OR excessive dressing lift requiring dressing replacement.

Trial Locations

Locations (5)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States

Virginia Commonwealth University Medical Center; 🇺🇸 Richmond, Virginia, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States